Job Title: Sr. Quality Systems Engineer
Location: Caesarea, Israel
Reports to: QA Director
Job Description: Responsible for QMS implementation, maintenance and effectiveness
Note: The following meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Key Responsibilities & Authorities:
Develop and maintain the company’s QMS. Establish efficient and compliant processes throughout the organization required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
Heads the CAPA program and provides professional guidance to CAPA owners and teams for effective and timely implementation of corrective and preventive actions.
Identifies quality metrics, analyzes and trends.
Responsible for the planning and execution of management reviews and resulting actions.
Responsible for planning and monitoring of the internal audit program.
Support and impacts in risk management, complaint handling, design and development and training efforts.
Host external audits and monitors resulting actions
BSc.in Electronics/HW/SW/Mechanics/ Physics from a well-known university MSc. in System Engineering
Minimum Experience: 7+ years of quality assurance in medical device companies.
Minimum of 5 years of middle management experience.
Extensive understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD etc.
Job Specific Skills (Languages, SW, systems, etc.'):
Excellent verbal and written communication skills (Hebrew and English).
Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems.
Other Requirements for the role (% of travel, etc.):
Ability to work in a team minded approach to achieve individual and company success.
Influences and impacts others through building and defending arguments, challenges in a provocative and respectful manner, reaches consensus of opinion, and catalyzes action to meet critical objectives.
Interpersonal and presentation skills.
Internal: All departments
External: Notified Body, FDA and other as required